A three period study conducted at clinics in the US, Europe and South America to compare the effectiveness of different doses of a new investigational drug, GSK573719, with placebo (no active treatment) in subjects with mild asthma

INTERVENTION: Product Name: GSK573719 Product Code: GSK573719 Pharmaceutical Form: Inhalation powder Current Sponsor code: GSK573719 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 15.6‐ Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use Product Name: GSK573719 Product Code: GSK573719 Pharmaceutical Form: Inhalation powder Current Sponsor code: GSK573719 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 31.25‐ Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use Product Name: GSK573719 Product Code: GSK573719 Pharmaceutical Form: Inhalation powder Current Sponsor code: GSK573719 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 62.5‐ Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use Product Name: GSK573719 Product Code: GSK573719 Pharmaceutical Form: Inhalation powder Current Sponsor code: GSK573719 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 125‐ Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use Product Name: GSK573719 Product Code: GSK573719 Pharmaceutical Form: Inhalation powder Current Sponsor code: GSK573719 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 250‐ Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use CONDITION: Asthma ; MedDRA version: 15.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 ‐ Respiratory, thoracic and mediastinal disorders Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: Main Objective: The primary objective is to evaluate the dose response, efficacy and safety of five once daily doses of GSK573719 (15.6mcg, 31.25mcg, 62.5mcg, 125mcg and 250mcg).; compared with placebo, over a minimum 14‐day treatment period, in patients with asthma. Primary end point(s): The primary efficacy endpoint is trough FEV1 on Day 15 end of each treatment period, defined as the FEV1 value obtained 24 hours after morning dosing on Day 14 visit of each treatment period (obtained on all subjects). Secondary Objective: The secondary objectives are to evaluate the efficacy and safety of two twice daily regimens of GSK573719 (15.6mcg, 31.25mcg) relative to placebo and relative to the once‐daily regimens of GSK573719 and to derive pharmacokinetic parameters for; GSK573719 administered once and twice daily in patients with asthma.; An additional objective is to determine whether there are differential responses to GSK573719 that can be predicted from patient characteristics. Timepoint(s) of evaluation of this end point: 24 Hours after morning dosing on day 14 visit of each treatment period. SECONDARY OUTCOME: Secondary end point(s): The following secondary efficacy endpoints are derived from the serial FEV1 measurements (obtained in the sub‐group only‐ see Appendix 4). ; • Weighted mean FEV1 over 0‐24 hours after morning dosing on Day 14 of each treatment period ; • Serial FEV1 at each timepoint over 24 hours after morning dosing on Day 14 of each treatment period or from the subject diary assessments (obtained in all subjects) ; • AM (pre‐dose and pre‐albuterol/salbutamol bronchodilator) PEF; calculated from the 7 days prior to each treatment period as baseline and the last 7 days of each treatment period ; • PM (pre‐dose and pre‐albuterol/salbutamol bronchodilator) PEF; calculated from the 7 days prior to each treatment period as baseline and the last 7 days of each treatment period ; • Rescue use albuterol/salbutamol calculated from the 7 days prior to each treatment period as baseline and the last 7 days of each treatment period. Timepoint(s) of evaluation of this end point: See E.5.2 INCLUSION CRITERIA: Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the GSK investigational product or other study treatment that may impact subject eligibility is provided in the Investigator Brochure for GSK573719, a muscarinic receptor antagonist and Inhaled Fluticasone Furoate (GW685698), a glucocorticoid receptor agonist. Deviations from inclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential. Subjects eligible for enrolment in the study must meet all of the following criteria: Informed consent: Subjects must give their signed and dated written informed consent to participate. Type of Subject: Out‐patients. However a sub‐group of subjects from selected sites will remain in the clinic overnight at the end of e